Community Pharmacists Provision of Pharmaceutical Care to the

Community Pharmacists’ Provision of Pharmaceutical Care to the Older Adult R. Grymonpre L. Vercaigne C. Metge P. Montgomery University of Manitoba

Community Pharmacists’ Expanded Role “There is strong evidence that clinical pharmacy services add value to patient care and reduce health care utilization costs…. clinical services are not widely provided in community pharmacy settings” The Clinical Role of the Community Pharmacist. Office of the Inspector General, USA. January 1990 “The judicious use of the professional qualifications of pharmacists [is encouraged]” The Rational Use of Drugs by the Elderly: A Strategy for Action. Government of Quebec. 1995 “National action to ensure appropriate use of all medication will require the active participation of …[seniors, physicians, pharmacists, nurses, governments, industry, family members and caregivers]” Federal/Provincial/Territorial Strategy for Action. Health Canada. June 1996

Community Pharmacists’ Expanded Role “The pharmacist is in an excellent position to monitor seniors’ medication use at the point of dispersal” Optimizing Medication Use in Seniors Receiving Home Care. Canadian Association Community Care. August 1997 “Pharmacists are perhaps both the most important – and least utilized – source of information and education about medications” Seniors, Diversity & Access: Medication Use & “Hard to Reach” Seniors. National Pensioners and Senior Citizens Federation. May 1997 “Pharmacists can play an increasingly important role as part of the primary health care team……this expanded role would allow pharmacists to consult with physicians and patients, monitor patients’ use of drugs, and provide better information and communication on prescription drugs. ” Building on Values: The Future of Health Care in Canada Final Report. Romanow RJ. (Commissioner) November 2002

Community Pharmacists’ Expanded Role Cochrane Review: • increased scheduled health services but no decrease in hospital and ER admissions (1 of 7 studies); • decreased hospital/ER admissions, number of specialty physician visits, numbers or costs of drugs, improved appropriateness of drugs (6 of 7 studies); • improvements in targeted condition but no change in quality of life or incidence of ADR (10 of 13 studies); • improvements in patient adherence (3 of 6 studies) • favorable changes in physician prescribing (9 of 10 studies) Beney J, Bero L, Bond C. Expanding the roles of outpatient pharmacists: effects on health services utilisation, costs, and patient outcomes (Cochrane Review). In: The Cochrane Library , Issue 1, 2004. Chichester, UK: John Wiley & Sons, Ltd.

Geriatric Pharmaceutical Care 2001: 12. 5% Canadians 65+ years old 2026: 20% of Canadians 65+ years old In Manitoba (1996): 13. 6% of population 65+ years old 34% of prescriptions dispensed average of 5 different drugs

Geriatric Pharmaceutical Care Life expectancy, at birth (1997): 75. 8 years for men 81. 4 years for women In one study of older persons, drugs contributed to 20% of hospitalizations Grymonpre et al J Am Geriatr Soc. 1988

Community-Based Geriatric Pharmacy Care 6 studies: Ø Positive results: Ø Improved adherence (1) Ø Excellent physician & patient acceptance (81% & 91%) (1); DRIs identified and resolved (2) Ø More appropriate drug use (1); more drug changes (1); fewer repeat prescriptions (1); reduced drug costs (1) Ø Reduced outpatient visits (1); reduced hospitalizations and hospital stays; reduced health care costs (1) Ø Negative results: Ø Ø No difference in SF-36 (1); no difference in health decline, falls (1) Poor physician acceptance (28%); DRIs identified but not resolved (1) No difference in numbers/costs of drug, medication adherence (1) no change in health services use (2)

Community-Pharmacists: Geriatric Pharmaceutical Care Bernsten C et al. Drugs & Aging 2001; 18(1): 63 -77 Design: randomized (by pharmacy), controlled Participants: 190 sites, 2, 454 patients, 65 years, 4 prescribed meds, oriented x 3, noninstitutionalized Intervention: pharmaceutical care for 18 months; community pharmacy Process measures: number of medications & changes; contacts with GP, GP acceptance & satisfaction; cost analysis; medication knowledge & adherence Outcome measures: SF-36, hospitalizations, symptoms (selfreported), patient satisfaction Results: improved satisfaction & symptom control, no difference in other measures

Community-Pharmacists: Geriatric Pharmaceutical Care Sellors J. SMART. Final report. Sept. 2000 Design: randomized, controlled Participants: 889 patients, 65 years, 5 prescribed meds, MMSE≥ 25, noninstitutionalized Intervention: pharmaceutical care; 24 community pharmacists Process measures: number and types of drug-related issues, resolution rate of issues, physician response, number of daily medications, medication units, & costs, inappropriate drugs, medication adherence Outcome measures: medication problems (self-reported), health care utilization and costs; SF-36 Results: DRIs identified in 88% of subjects (mean 3. 2); 84% physician acceptance; 57% MD implementation; no difference in other measures.

Community-Based Geriatric Pharmacy Care Grymonpre RE et al Int J Pharm Pract 2001; 9: 235 -41 Ø Design: randomized, controlled Ø Participants: 135 patients, 65 years, noninstitutionalized, 2 medications Ø Intervention: pharmaceutical care for 1 year; ‘wellness clinic’ Ø Process measures: number and types of drug-related issues, resolution rate of issues, physician response, number & costs of medications, medication knowledge & adherence Ø Outcome measures: symptoms (self-reported) Ø Results: 952 issues identified, 29% resolution rate; positive MD response but 28% acceptance rate (by survey); no difference in other measures

Hypothesis Community pharmacists have the necessary skills and knowledge to improve drug taking behaviour of older adults and the prescribing habits of physicians, thereby optimizing disease control and reducing the amount of drug-related illness in this segment of the population.

Manitoba Pharmaceutical Care Project Research Questions: Ø Can a workable model of community-based pharmaceutical care be provided to physicians and elderly patients? Ø What is the impact of community pharmacists practicing pharmaceutical care on: • Physician and patient acceptance and implementation of recommendations? • Use of medications by older persons?

Objectives: To document measures of the patient-focussed pharmacy care provided: numbers and types of drug-related issues identified; numbers and types of recommendations made; physician and patient acceptance of recommendations; endpoints of plans of action; interview and work-up times; level of remuneration To measure the impact of comprehensive patient-focussed pharmacy on: medication adherence (primary measure); numbers and costs of medications

Methods: Pharmacy & Pharmacist Selection Ø Invitation for participation and application Ø Selection based on criteria & signed contract: ü demonstrate an understanding of pharmaceutical care ü removed from dispensing activities for 6 hours/week ü recruit 1 client/week x 74 weeks ü provide pharmaceutical care to patients ü agree to training & group sessions ü complete and submit required documentation ü access to confidential area ü space & equipment for maintaining files ü access to library of references

Methods: Process of Care Intervention Ø Eligible clients perceived to be at risk recruited Ø Intervention: Comprehensive patient-focussed pharmacy care ümedication history ü develop, implement and document patient care plans: identification of drug-related issues o intervention (MD &/or client) o follow-up o Ø Remuneration provided

Methods: Process of Care Action Plan Ø Characterized by a single or multiple drug-related issue(s) and disease state(s) Ø Requiring a single or multiple recommendation(s) Ø Resulting in one desired endpoint Issues: undertreated diabetes, lack of knowledge, condition requiring monitoring Recommendations: add drug, educate client, refer to dietician, monitor blood sugars Acceptance: client and MD accepted recommendations Endpoint: blood sugars normalized

Methods: Process of Care Endpoint Ø Dependent on issue(s) identified in plan of action ü health outcome - clinical issue • symptom/measure of disease or side effect: BP, BS, pain, constipation ü process endpoint – drug issue • no indication, wrong drug, overdose • when not feasible to look at clinical endpoint (immunization, osteoporosis, stroke prophylaxis) • education & nonadherence Ø Status of issue at follow-up Ø ‘partially resolved’ - positive trend but desired target not reached

Methods: Research design Design: prospective, nonrandomized, controlled, beforeafter trial, survey and population based Setting: community pharmacies Study Subjects: ‘convenience’ sample; 65+ years old; noninstitutionalized; willing to provide signed informed consent; taking at least 1 medication Control Subjects: randomly selected from Manitoba Health database; 3: 1 match by age, gender, and ‘Adjusted Clinical Group’

Methods: Process Measures Population based measures: medication adherence (primary measure); numbers and costs of medications Survey based measures (test only): interview and work-up times; remuneration; numbers and types of drug-related issues identified; numbers and types of recommendations made; physician and patient acceptance of recommendations; endpoints of plans of action

Methods: Data analysis Population based data: ØRequired sample size (total) = 220 § 10% change in medication adherence § = 0. 10 = 0. 05 § std deviation 25% (Annals 1998) Ø Mixed modeling procedure (SAS)

Medication Adherence: Cumulative Medication Acquisition (CMA) CMA* = ‘days supply’ in interval actual number of days in interval *CMA values are only calculated on medications with 3 or more fills and a ‘prescribed rate’ (quantity dispensed ‘days supply’) of 0. 5, 1, 1. 5, 2. 0, 2. 5, 3. 0, 3. 5, 4. 0, 4. 5. Using these criteria, DPIN was determined to be a valid measure of medication adherence compared to pill count with 77% concordance & Mc. Nemar’s p=0. 6837 Grymonpre RE et al [ABSTRACT] Can J Clin Pharm (in press) 2004

Remuneration: Pharmacy Consultation Grymonpre et al J Res Pharm Econ 2001: 11(1): 51 -61

Results: Pharmacy recruitment Ø Total number of pharmacies: 11 (selected from 15 applicants) Ø Total number of test pharmacists: 15 Ø Orientation session: May 1 & 2, 1998 (9 hours) Ø Ongoing one-on-one support with resource pharmacist and groups sessions.

Results: Client recruitment Ø Study duration: May 1, 1998 - Jan 31, 2000 Ø Total number of clients evaluated: 337 Ø Total number of eligible clients: 213 (63%) Ø 124 Exclusions: no consent insufficient documentation 78 46

Results: Demographic Data

Results: Drug Benefit Plans No 3 rd party coverage 70/126 (56%) Blue Cross 42/126 (33%) Dept. Veterans Affairs 9/126 (7%) Other* 5/126 (4%) *Great West Life, Indian Affairs, Assure

Results: Time required

Results: Action Plans Ø 211 of 213 clients had 1 Action Plan Ø 732 Action Plans were developed Ø mean of 3. 5 1. 7 person Ø characterized by 945 drug-related issues Ø involving 1005 recommendations

945 Drug-Related Issues

Recommendations to physician Of 1005 recommendations made: Ø 499 (50%) recommendations involved the MD Ø 114 (23%) of 499 recommendations to MD not made/documented

385 recommendations made to MD: • • • start drug stop drug switch drug monitor therapy decrease dose • increase dose 80 61 61 54 29 (21%) (16%) (14%) ( 8%) 28 ( 7%) • • • dispensing task 12 (3%) change dosing time 11 (3%) refer other hcp 9 (2%) change dose form 8 (2%) encourage adherence 5 (1%) other 27 (7%)

Physician response Of 385 recommendations made to MD : Ø physician response to 87 (23%) unknown Ø Of 298 known responses: • 82% accepted and • 4% partially accepted

Recommendations to patient Of 1005 recommendations made: Ø 1003 (99. 8%) recommendations involved patients Ø 89 (9%) required recommendations to patients not made/documented

914 recommendations to patient • • educate 153 (17%) • start drug 127 (14%) • monitor 122 (13%) • change drug 92 (10%) • stop drug 76 (8%) • disp. related task 48 (5%) • increase dose 43 (5%) • compliance aid decrease dose nonpharm. advice change time enc. adherence refer to hcp other 43 (5%) 41 (4%) 38 (4%) 34 (4%) 25 (3%) 38 (4%)

Patient response Of 914 recommendations made to patient: Ø patient response to 142 (16%) unknown Ø Of 772 known responses: • 90% accepted and • 3% partially accepted

Endpoints of 732 Plans of Action Of 732 Plans of Action: Ø Endpoint unknown for 278 (38%) Ø Of 454 documented endpoints, 344 (76%) were resolved or partially resolved.

Medication Adherence: Pre- versus Post- Intervention 199 Test vs 506 Control Subjects P=0. 0064

Number of Different Drugs: Pre- versus Post- Intervention 199 Test vs 506 Control Subjects P=0. 0044

Annual drug costs: Pre- versus Post- Intervention 199 Test vs 506 Control Subjects P=0. 0716

Summary Some difficulties with process: ütarget recruitment rate of 1 client/week could not be met ü 23% recomm. involving MD not made/documented ü 9% recomm. involving patient not made/documented ü 23% of MD responses not determined/documented ü 16% of patient responses not determined/ documented ü 38% of endpoints not determined/documented

Summary When process successfully implemented & documented: Ø 99% of clients experienced 945 drug-related issues requiring 1005 recommendations Ø 86% physician acceptance rate Ø 93% patient acceptance rate Ø positive endpoints achieved for 76% action plans

Benefits: Health & Health Costs Compared to control subjects, test subjects had: Ø a lower rate of increase in numbers of drugs (p=0. 004) Ø a lower rate of increase in costs of drugs (p=0. 07) Ø greater improvements in medication adherence (p=0. 006)

Conclusions Ø The delivery & documentation of pharmaceutical care was challenging & required one-on-one support by a resource pharmacist Ø Older adults experienced several drug related issues Ø Community pharmacists had the necessary skills and knowledge to identify & resolve these issues which resulted in desired process endpoints and health outcomes Ø Community pharmacists providing patient focussed care reduced numbers and costs of medications and improved medication adherence

Acknowledgements J Apotex Inc. J CIHR (formerly NHRDP) J Centre on Aging J Manitoba Health J Manitoba Pharmacists J Manitoba Pharmaceutical Association J Manitoba Society for Pharmacists J Jenny Kleine Golden (1972 -2002)

Acknowledgements J J J J Ms. Marie Berry (Vimy Park Pharmacy) Mrs. Carol Boscow (The Pas Super Thrifty) Mrs. Barbara Bromilow (Pharmasave Beasejour) Mrs. Donna Campbell (Pharmasave) Mr. Bill Cechvala (Vimy Park Pharmacy) Mr. Terry Chan (Shoppers Drug Mart) Mrs. Wendy Clark (Carman Pharmacy) Mrs. Morna Cook (Dixon’s Pharmacy) Ms. Shelley Cowie (Shoppers Drug Mart) Ms. Camella Crook (C&C PC and Consulting) Mr. Quy Doan (Shoppers Drug Mart) Mr. Brian Dusik (St. James Pharmacy) Mrs. Michele Fontaine (Shoppers Drug Mart) Mr. Myles Haverluck (Dauphin Clinic Pharmacy) Mr. Warren Hicks (The Pas Super Thrifty Drug Mart) Mr. Rob Jaska (Medical Centre Pharmacy) J Mrs. Nadine Karpinski (Shoppers Drug Mart) J Mr. Darryl Lancaster (Pharmasave) J Mrs. Tracy Lelong-Young (Prescription Plus Pharmacy) J Mrs. Donna Mc. Leod (Pharmasave) J Mrs. Nancy Metcalfe (Pfahl’s Drugs Ltd. ) J Mr. Real Mulaire (St. Pierre Pharmacy) J Mrs. Lisa Olench (Pharmasave) J Mrs. Julie Penelton (St. James Pharmacy) J Mr. Sigfried Pfahl (Pfahl’s Drugs Ltd. ) J Mr. Don Radley (Pharmasave) J Mrs. Nancy Remillard (Pharmasave) J Mr. Jay Rich (Shoppers Drug Mart) J Mr. Mark Scott (Shoppers Drug Mart) J Mr. Trevor Shewfelt (Dauphin Clinic Pharmacy) J Mr. Rolland Villar (Shoppers Drug Mart) J Mrs. Sonia Wriedt (Pharmasave)